Wrong Way: Degradation Puts Children at Risk
There are a lot of ways to monitor a vaccine. According to the CDC, though, there’s only one right way to do it. That’s true, at least, if you believe that regulations in place that support their Vaccines for Children (VFC) program should be industry wide.
The VFC is something we’ve discussed with regularity here, both on our blog and in our Insights magazine. Here’s a recap of the program as defined by the CDC.
“The Vaccines for Children (VFC) program offers vaccines at no cost to eligible children through health care providers enrolled in the program. Vaccinating on time means healthier children, families, and communities.
“Children who are eligible for the Vaccines for Children (VFC) program can receive vaccines at no cost through a national network of participating health care providers. The VFC program helps ensure that all children have a better chance of getting their recommended vaccinations on schedule. These vaccines protect babies, young children, and adolescents from 16 diseases”
In order to qualify for the program, children must fit one of the four criteria while being under 18 years of age. They’re either American Indian or Alaska Native, Medicaid-eligible, uninsured, or underinsured. While the cost of the vaccine is waived, it’s possible that a doctor may still charge the patient for the visit and services performed.
There are a number of criteria that need to be met as defined by the CDC to be a medical provider that delivers these vaccines to those in need. According to the American Academy of Pediatrics, all VFC providers must now employ continuous monitoring solutions with a backup system that can be easily read via a screen on the outside of the cold storage. Clinics must also review and assess data each morning.
The CDC gets more specific in their Vaccine Storage Toolkit. The data logger you choose must be digital in nature and have a valid and current certificate of calibration. The organization also makes a number of recommendations outside of their requirements.
- Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®)
- Alarm for out-of-range temperatures
- Low-battery indicator
- Current, minimum, and maximum temperature display
- Recommended uncertainty of +/-0.5° C (+/-1° F)
- Logging interval (or reading rate) that can be programmed by the user to measure and
record temperatures no less frequently than every 30 minutes
Many of our VFC customers have found our DicksonOne offerings as a way to meet their needs and those that have been outlined by the regulatory body. Our replaceable thermistor sensor is buffered with glycol or glass beads and allows recalibration to take place without removing the device from service. The system itself can even notify relevant team members via call, text, or email in the event of any excursion. DicksonOne also checks all the rest of the boxes laid out above.
These guidelines and requirements aren’t outlined just because. They’re in place because temperature has a very direct impact on the validity of a vaccine. We discussed this in 2016 as we investigated how the Arrhenius Equation impacted vaccine degradation. What we found supports the needs for such strict monitoring.
“A number of vaccines are unable to be freeze-dried and need to be kept as close to 40°F as possible. These vaccines have been the topic of numerous testing to determine the potency of the medicine after freezing and the results haven’t been promising. A freeze-thaw test on four batches of tetanus showed a 14.5% regression in potency following a single freeze-thaw and a 61.5% regression after two rounds of freezing. Similar tests have shown comparable results across a variety of different inoculations.”
That’s pretty extreme from a freeze/thaw perspective, but the data gets even worse when it comes to heating the vaccines.
“Vaccines that would normally last two years when kept refrigerated, can last as little as days when warmed. The BCG vaccine that is primarily used against tuberculosis becomes fully degraded after 48 hours at room temperature. As you can imagine, it’s important to keep all vaccines in peak condition for patient safety, but the rising costs of the drugs make it imperative for offices to get as much out of them as they can.”
That means that partnering with Dickson doesn’t just keep you compliant to VFC guidance. It means keeping children safe and appropriately inoculated. It’s about avoiding degradation. That should be reason enough to monitor them the only way the CDC deems fit.